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Enable Injections

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uuid00007f2

Namestring
Enable Injections
Legal namestring
Enable Injections, Inc.
Company typeenum
Private
Founded yearint
2010
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
101–250
akta.pro rankint
HeadquartersCincinnati, United States
HQ citystring
Cincinnati
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices4 records

Each record includes

City, Country, Type, Description, Source

Keyword5 values
wearable drug delivery, on-body injectors, subcutaneous delivery systems, biologics combination products, large-volume injectors
Industry3 codes
1Wearable Injectors & On-Body Delivery Systems
CodeHLAHAIAEPrimaryYes
2Drug Delivery Connectivity, Sensors & Digital Add-Ons (Smart Caps/Companion Apps)
CodeHLAHAIAMPrimaryNo
3Connected Therapeutics & Smart Drug Delivery Monitoring
CodeHLACAFALPrimaryNo
NAICS code3 codes
  • Electromedical and Electrotherapeutic Apparatus Manufacturing334510
  • Surgical and Medical Instrument Manufacturing339112
  • Medical Equipment and Supplies Manufacturing3391
SIC code2 codes
  • Surgical & Medical Instruments & Apparatus3841
  • Electromedical & Electrotherapeutic Apparatus3845
Product category
Wearable Drug Delivery Devices
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model3 records
1Device Manufacturing and Supply
TypeHardware Sales
Description

Enable manufactures and supplies enFuse devices to pharmaceutical partners for clinical and commercial use. Partners pay transfer price for clinical and commercial supply of enFuse devices.

enableinjections.com
2Partnership Licensing and Milestones
TypeLicensing Royalties
Description

Partners obtain exclusive licenses to use enFuse technology with specific therapeutics. Enable receives upfront technology access fees, potential R&D milestones, commercial milestones, product sales, and single digit royalties.

enableinjections.com
3Strategic Investment
TypeManaged Services
Description

Enable receives strategic investments from pharmaceutical partners (e.g., $30M from Sanofi in January 2026) to accelerate manufacturing capabilities and supply chain development.

finsmes.com
Marketing channels5 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components6 values
Technology or R&D, Supply Chain, Operations, Personnel, Marketing or Sales, Infrastructure
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 of 4 records shown
1enFuse
Description

The enFuse wearable drug delivery platform designed to deliver large volumes of medications subcutaneously, featuring hands-free wearable technology for patient self-administration.

enableinjections.com
+3 more records
Core offering1 text field

Enable Injections develops and manufactures the enFuse wearable drug delivery platform, a hands-free, purely mechanical on-body injector that delivers large volumes (5-25 mL per device, up to 100 mL with four simultaneous devices) of pharmaceutical and biologic therapeutics subcutaneously. The company works with pharmaceutical and biotech partners under licensing and supply agreements, providing devices for clinical trials and commercial combination products.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 5 values shown
  • 100% of surveyed patients preferred enFuse over infusion pump in randomized control trial (SCIg study)
+4 more records
Product and service4 records
1enFuse Wearable Drug Delivery Platform
CategoryWearable Drug Delivery Devices
Description

Hands-free, purely mechanical on-body injector for subcutaneous delivery of 5-25 mL of pharmaceuticals and biologics; four devices can be worn simultaneously for up to 100 mL. Designed for at-home or in-clinic self-administration. Supplied to pharmaceutical partners for combination product development and commercialization.

2EMPAVELI Injector
CategoryCommercial Combination Product
Description

First commercial enFuse-based combination product, FDA-approved for at-home self-administration of pegcetacoplan (Apellis) for PNH, C3G, and primary IC-MPGN. Sold by Apellis in the US.

3ASPAVELI enFuse On-Body Delivery System
CategoryCommercial Combination Product
Description

CE-certified enFuse-based combination product for subcutaneous administration of Aspaveli (pegcetacoplan) for patients 12 years and older with PNH, C3G, and primary IC-MPGN; distributed by Sobi across the European Union.

4CirCLIQ On-Body Injector (Sarclisa SC)
CategoryCommercial Combination Product
Description

enFuse-based on-body injector used to deliver Sanofi's Sarclisa (isatuximab) subcutaneous formulation for multiple myeloma; the first anticancer treatment approved in the EU for administration via a portable injector.

Scale indicator9 records

Each record includes

Type, Value, Description, Source

Partnership9 partners
Strategic tierCoreTypeTechnology or IntegrationAnnounced on2026-04-08
Description

Aptar Digital Health named Enable's preferred digital health partner for enFuse On-Body Delivery System. Partnership delivers companion digital solution including treatment data recording, onboarding modules, injection guidance, patient-reported outcomes, and symptom tracking. Solution expected to launch H2 2026.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2025-10-27
Description

Incyte obtained worldwide exclusive license to use enFuse technology with its mutCALR-targeted therapy (INCA033989) in essential thrombocythemia (ET) and myelofibrosis (MF). Enable receives upfront technology access fee, R&D milestones, commercial milestones, and transfer price for device supply.

Strategic tierCoreTypeChannel Partner/ Reseller/ DistributorAnnounced on2024-09-12
Description

Development and distribution agreement for enFuse Injector for subcutaneous delivery of Aspaveli (pegcetacoplan). Sobi distributes ASPAVELI enFuse in European territories. Regulatory approvals obtained in EU (CE Mark 2026), Saudi Arabia, Brazil, South Korea, Canada.

Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2024-05-15
Description

Partnership to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse for advanced Parkinson's disease. Serina obtains worldwide exclusive license; Enable receives upfront fees, milestones, royalties. Clinical trial planned for Q4 2025.

Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2023-05-08
Description

Partnership to support one of Viridian's preclinical programs using enFuse technology for subcutaneous drug delivery.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2021-05-17
Description

EMPAVELI Injector (enFuse-based) received FDA approval in 2023 for subcutaneous delivery of pegcetacoplan for paroxysmal nocturnal hemoglobinuria. First commercial enFuse combination product. Apellis commercializes EMPAVELI Injector in the US.

Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2019-08-20
Description

Partnership to integrate Roche's proprietary molecules with Enable's enFuse wearable drug-delivery technology, enabling patients to self-administer high-volume subcutaneous injections at home. Partnership expanded in May 2024.

Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2018-11-13
Description

Strategic partnership for development of subcutaneous drug delivery solutions using enFuse technology.

Strategic tierMinorTypeStrategic or Co-development PartnerAnnounced on2018-11-13
Description

Strategic partnership for development of subcutaneous drug delivery solutions using enFuse technology.

Recent move7 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

West's Device and Containment Solutions unit offers on-body wearable injectors (SmartDose, ContraFLO, and other platforms) for large-volume SC delivery. Closest direct competitor to Enable's enFuse, partnering with multiple large pharma companies across the same therapeutic areas.

TypeBroad incumbent
Description

BD's Pharmaceutical Systems unit offers the Libertas wearable on-body injector plus a broad prefilled syringe and device portfolio. Comparable via large-volume SC combination products; competes from a much larger medtech incumbent position.

TypeDirect peer
Description

Swiss device manufacturer with YpsoDose, a 2-step wearable injector for 1–10 mL SC delivery and broader pen/injector platforms. Directly competes for the same large-volume SC partnership deals with pharma companies.

TypeDirect peer
Description

Italian manufacturer offering the On-Body Delivery System (OBDS) for large-volume SC biologics, plus integrated vial and syringe solutions. Directly comparable on-body technology competing for similar pharma combination-product opportunities.

TypeDirect peer
Description

Developer of wearable injectors including the Molly and Maggie autoinjector/wearable platforms. Directly comparable large-volume wearable technology competing with enFuse for pharma partnership wins.

TypeDirect peer
Description

Contract developer of drug-delivery devices including on-body wearable injectors for pharma partners. Overlaps with Enable in B2B combination-product development and large-volume SC delivery engineering services.

TypeEmerging player
Description

Primary packaging and drug-delivery device company expanding into on-body injectors and large-volume SC systems. Comparable as a newer entrant building a wearable delivery platform for pharma partners.

TypeOthers
Description

Digital health and drug delivery partner whose Aptar Digital Health division is Enable's preferred digital companion partner. Adjacent/complementary ecosystem participant rather than direct competitor.

TypeBroad incumbent
Description

Lilly has invested heavily in internal and partnered wearable on-body injector development for large-volume biologics (e.g., insulin, GLP-1, oncology). Competes as a vertically integrated pharma developing or sourcing similar delivery technology.

TypeOthers
Description

Enable's largest strategic investor and Sarclisa SC partner via CirCLIQ. Sanofi also explores alternative internal and external delivery platforms, making it both a partner and a structural risk to Enable's pipeline concentration.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat6 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers3 records

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature7 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles18 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds8 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors12 records

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Enable Injections

Wearable Drug Delivery Devicesenableinjections.com

Enable Injections firmographics

Firmographics
Name
Enable Injections
Legal name
Enable Injections, Inc.
Website
https://enableinjections.com
Company type
Private
Founded year
2010
Operating status
Operating
Headcount range
101–250 employees
Ownership category
akta.pro rank

Enable Injections industry classification

Industry
Product category
Wearable Drug Delivery Devices
NAICS
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical and Medical Instrument Manufacturing (339112), Medical Equipment and Supplies Manufacturing (3391)
SIC
Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)
akta.pro primary industry
Wearable Injectors & On-Body Delivery Systems (HLAHAIAE)
akta.pro secondary industries
Drug Delivery Connectivity, Sensors & Digital Add-Ons (Smart Caps/Companion Apps) (HLAHAIAM), Connected Therapeutics & Smart Drug Delivery Monitoring (HLACAFAL)

Keywords

  • Wearable drug delivery
  • On-body injectors
  • Subcutaneous delivery systems
  • Biologics combination products
  • Large-volume injectors

Where Enable Injections is headquartered

Location

Headquarters

HQ city
Cincinnati
HQ country
United States
HQ region
North America

Offices4 records

Markets served

Enable Injections business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Supply Chain, Operations, Personnel, Marketing or Sales, Infrastructure

Revenue model

  1. Device Manufacturing and Supply: Enable manufactures and supplies enFuse devices to pharmaceutical partners for clinical and commercial use. Partners pay transfer price for clinical and commercial supply of enFuse devices.
  2. Partnership Licensing and Milestones: Partners obtain exclusive licenses to use enFuse technology with specific therapeutics. Enable receives upfront technology access fees, potential R&D milestones, commercial milestones, product sales, and single digit royalties.
  3. Strategic Investment: Enable receives strategic investments from pharmaceutical partners (e.g., $30M from Sanofi in January 2026) to accelerate manufacturing capabilities and supply chain development.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Enable Injections product offering

Product offering

Core offering

Enable Injections develops and manufactures the enFuse wearable drug delivery platform, a hands-free, purely mechanical on-body injector that delivers large volumes (5-25 mL per device, up to 100 mL with four simultaneous devices) of pharmaceutical and biologic therapeutics subcutaneously. The company works with pharmaceutical and biotech partners under licensing and supply agreements, providing devices for clinical trials and commercial combination products.

Differentiator

Problem solved

Functional benefit

Brands

  • enFuse: The enFuse wearable drug delivery platform designed to deliver large volumes of medications subcutaneously, featuring hands-free wearable technology for patient self-administration.
  • EMPAVELI Injector
  • ASPAVELI enFuse
  • CirCLIQ

Products and services

  • enFuse Wearable Drug Delivery Platform Hands-free, purely mechanical on-body injector for subcutaneous delivery of 5-25 mL of pharmaceuticals and biologics; four devices can be worn simultaneously for up to 100 mL. Designed for at-home or in-clinic self-administration. Supplied to pharmaceutical partners for combination product development and commercialization.
  • EMPAVELI Injector First commercial enFuse-based combination product, FDA-approved for at-home self-administration of pegcetacoplan (Apellis) for PNH, C3G, and primary IC-MPGN. Sold by Apellis in the US.
  • ASPAVELI enFuse On-Body Delivery System CE-certified enFuse-based combination product for subcutaneous administration of Aspaveli (pegcetacoplan) for patients 12 years and older with PNH, C3G, and primary IC-MPGN; distributed by Sobi across the European Union.
  • CirCLIQ On-Body Injector (Sarclisa SC) enFuse-based on-body injector used to deliver Sanofi's Sarclisa (isatuximab) subcutaneous formulation for multiple myeloma; the first anticancer treatment approved in the EU for administration via a portable injector.

Quantifiable outcome

  • 100% of surveyed patients preferred enFuse over infusion pump in randomized control trial (SCIg study)
  • +4 more outcomes

Companies that use Enable Injections

Customer profile

Named customers3 records

Segments2 records

Ideal customer profiles1 record

Enable Injections technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature7 records

Enable Injections partnerships and signals

Strategic signal

Partnerships

Nine partnerships are on record, tiered core and minor.

  • Aptar Digital HealthcoreTechnology or Integration · 8 April 2026Aptar Digital Health named Enable's preferred digital health partner for enFuse On-Body Delivery System. Partnership delivers companion digital solution including treatment data recording, onboarding modules, injection guidance, patient-reported outcomes, and symptom tracking. Solution expected to launch H2 2026.
  • IncytecoreStrategic or Co-development Partner · 27 October 2025Incyte obtained worldwide exclusive license to use enFuse technology with its mutCALR-targeted therapy (INCA033989) in essential thrombocythemia (ET) and myelofibrosis (MF). Enable receives upfront technology access fee, R&D milestones, commercial milestones, and transfer price for device supply.
  • Sobi (Swedish Orphan Biovitrum)coreChannel Partner/ Reseller/ Distributor · 12 September 2024Development and distribution agreement for enFuse Injector for subcutaneous delivery of Aspaveli (pegcetacoplan). Sobi distributes ASPAVELI enFuse in European territories. Regulatory approvals obtained in EU (CE Mark 2026), Saudi Arabia, Brazil, South Korea, Canada.
  • Serina TherapeuticsminorStrategic or Co-development Partner · 15 May 2024Partnership to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse for advanced Parkinson's disease. Serina obtains worldwide exclusive license; Enable receives upfront fees, milestones, royalties. Clinical trial planned for Q4 2025.
  • Viridian TherapeuticsminorStrategic or Co-development Partner · 8 May 2023Partnership to support one of Viridian's preclinical programs using enFuse technology for subcutaneous drug delivery.
  • Apellis PharmaceuticalscoreStrategic or Co-development Partner · 17 May 2021EMPAVELI Injector (enFuse-based) received FDA approval in 2023 for subcutaneous delivery of pegcetacoplan for paroxysmal nocturnal hemoglobinuria. First commercial enFuse combination product. Apellis commercializes EMPAVELI Injector in the US.
  • Roche (Genentech)coreStrategic or Co-development Partner · 20 August 2019Partnership to integrate Roche's proprietary molecules with Enable's enFuse wearable drug-delivery technology, enabling patients to self-administer high-volume subcutaneous injections at home. Partnership expanded in May 2024.
  • UCBminorStrategic or Co-development Partner · 13 November 2018Strategic partnership for development of subcutaneous drug delivery solutions using enFuse technology.
  • CSLminorStrategic or Co-development Partner · 13 November 2018Strategic partnership for development of subcutaneous drug delivery solutions using enFuse technology.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Enable Injections competitors and assessment

Company assessment

Direct peers

  • West Pharmaceutical Services: West's Device and Containment Solutions unit offers on-body wearable injectors (SmartDose, ContraFLO, and other platforms) for large-volume SC delivery. Closest direct competitor to Enable's enFuse, partnering with multiple large pharma companies across the same therapeutic areas.
  • Ypsomed: Swiss device manufacturer with YpsoDose, a 2-step wearable injector for 1–10 mL SC delivery and broader pen/injector platforms. Directly competes for the same large-volume SC partnership deals with pharma companies.
  • Stevanato Group: Italian manufacturer offering the On-Body Delivery System (OBDS) for large-volume SC biologics, plus integrated vial and syringe solutions. Directly comparable on-body technology competing for similar pharma combination-product opportunities.
  • SHL Medical: Developer of wearable injectors including the Molly and Maggie autoinjector/wearable platforms. Directly comparable large-volume wearable technology competing with enFuse for pharma partnership wins.
  • Phillips-Medisize (Molex): Contract developer of drug-delivery devices including on-body wearable injectors for pharma partners. Overlaps with Enable in B2B combination-product development and large-volume SC delivery engineering services.

Broad incumbents

  • Becton Dickinson (BD): BD's Pharmaceutical Systems unit offers the Libertas wearable on-body injector plus a broad prefilled syringe and device portfolio. Comparable via large-volume SC combination products; competes from a much larger medtech incumbent position.
  • Eli Lilly (delivery platform): Lilly has invested heavily in internal and partnered wearable on-body injector development for large-volume biologics (e.g., insulin, GLP-1, oncology). Competes as a vertically integrated pharma developing or sourcing similar delivery technology.

Emerging players

  • Gerresheimer: Primary packaging and drug-delivery device company expanding into on-body injectors and large-volume SC systems. Comparable as a newer entrant building a wearable delivery platform for pharma partners.

Others

  • Aptar Pharma: Digital health and drug delivery partner whose Aptar Digital Health division is Enable's preferred digital companion partner. Adjacent/complementary ecosystem participant rather than direct competitor.
  • Sanofi (internal delivery): Enable's largest strategic investor and Sarclisa SC partner via CirCLIQ. Sanofi also explores alternative internal and external delivery platforms, making it both a partner and a structural risk to Enable's pipeline concentration.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

Enable Injections social profiles

Digital presence

Enable Injections financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Enable Injections leadership team

Management profile

Number of profiles

Profiles18 records

Enable Injections funding detail

Funding detail

Funding overview

Funding rounds8 records

Investors12 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Enable Injections M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Enable Injections

What does Enable Injections do?

Enable Injections develops and manufactures the enFuse wearable drug delivery platform, a hands-free, purely mechanical on-body injector that delivers large volumes (5-25 mL per device, up to 100 mL with four simultaneous devices) of pharmaceutical and biologic therapeutics subcutaneously. The company works with pharmaceutical and biotech partners under licensing and supply agreements, providing devices for clinical trials and commercial combination products.

Is Enable Injections a public or private company?

Enable Injections is a private company. It is classified as venture growth investor backed and is currently operating.

When was Enable Injections founded?

Enable Injections was founded in 2010. It employs 101 to 250 people.

Where is Enable Injections based?

Enable Injections is headquartered in Cincinnati, United States, in the North America region.

How does Enable Injections make money?

Three revenue lines are on record. Device Manufacturing and Supply is the primary driver. The others are partnership Licensing and Milestones and strategic Investment.

Who are Enable Injections's main competitors?

Direct peers on record are West Pharmaceutical Services, Ypsomed, Stevanato Group, SHL Medical and Phillips-Medisize (Molex). Broad incumbents are Becton Dickinson (BD) and Eli Lilly (delivery platform). Gerresheimer is listed as an emerging player. Others are Aptar Pharma and Sanofi (internal delivery).

Does Enable Injections have an API?

No public API is recorded for Enable Injections.

What industry is Enable Injections in?

Enable Injections's product category is Wearable Drug Delivery Devices. Its primary akta.pro industry code is HLAHAIAE, Wearable Injectors & On-Body Delivery Systems, with a secondary code of HLAHAIAM, Drug Delivery Connectivity, Sensors & Digital Add-Ons (Smart Caps/Companion Apps). Its NAICS code is 334510 and its SIC code is 3841.

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Live signals
PharmExecFDA Approves Enable Injections’ Wearable InjectorEnable Injections announced FDA approval of its wearable injector, the Empaveli Injector, for adults with paroxysmal nocturnal hemoglobinuria. The device enables hands-free subcutaneous drug delivery of up to 25 mL for at-home or in-clinic use. CEO Michael Hooven said the approval enhances patient experience and the company plans to grow enFuse partnerships.pharmaphorumChallenging conventional wisdom on injectables, with Mehul DesaiA survey presented at the AAPS National Biotechnology conference found that many commercially viable drug programs were abandoned due to misconceptions about subcutaneous drug delivery limits. Mehul Desai, VP of medical affairs at Enable Injections, discussed the findings and the company's enFuse on-body delivery system, which partners with Apellis, Sanofi, Roche, and CSL Behring.WKRCCincinnati unicorn touts 'most significant event' in its historyThe FDA approved the CirCliq injector for use with Sanofi's Sarclisa in multiple myeloma patients. The device, based on Enable Injections' enFuse technology, is a hands-free wearable drug delivery system. Enable CEO Mike Hooven called the approval the most significant milestone in the company's 16-year history.American City Business JournalsSanofi, Enable Injections get FDA nod for CirCliq deviceSanofi and Enable Injections have received FDA approval for their CirCliq device, marking a milestone for Enable Injections as a 'local unicorn.' The companies continue to expand hiring in the region, though the full article content is unavailable behind a paywall.DrugdeliverybusinessInside the Enable Injections enFuse drug delivery wearableSanofi's Enable Injections enFuse wearable received FDA approval in July 2026 for the first on-body anticancer injection. The device, approved in 2023 for paroxysmal nocturnal hemoglobinuria, uses a simple elastomeric balloon and needle, avoiding complex electronics.MedicaldesignandoutsourcingInside the first-of-its-kind Enable Injections enFuse drug delivery wearableEnable Injections' enFuse wearable drug delivery device received FDA approval in July 2026 for anticancer therapy, with initial approval in 2023 for paroxysmal nocturnal hemoglobinuria. The device uses a silicone balloon and retractable needle, with a tissue tent to reduce pain and leakage. The company plans to expand drug compatibility.MarketScreenerSanofi Receives Fda Approval for Subcutaneous Sarclisa Escena Administered Via On-Body InjectorSanofi received FDA approval for subcutaneous Sarclisa (isatuximab-irfc) Escena, the first anticancer treatment deliverable through both an on-body injector and manual subcutaneous administration, for use across all existing indications of the intravenous formulation in multiple myeloma. The pivotal IRAKLIA phase 3 study demonstrated non-inferior efficacy with 71.1% objective response rate versus 70.5% for IV administration, while significantly reducing infusion-related reactions from 25% to 1.5% and shortening treatment time. The approval leverages Enable Injections' hands-free on-body injector technology to deliver high-volume subcutaneous medicine, potentially transforming the patient experience in multiple myeloma treatment.Mpo-magAptar Digital Health, Enable Injections Team Up on enFuse Companion Digital SolutionAptar Digital Health and Enable Injections Inc. have announced a strategic partnership making Aptar Digital Health the preferred digital health partner for Enable's enFuse on-body drug delivery system. The companion digital solution will provide features including treatment data recording, onboarding modules, injection guidance, patient-reported outcomes, and symptom tracking to support patient adherence throughout the injection process. The solution will be deployed alongside the enFuse system to help pharmaceutical partners capture adherence data and generate actionable insights from clinical trials through commercialization.MarketScreenerBrussels greenlights subcutaneous administration for Sanofi's SarclisaThe European Commission approved the subcutaneous formulation of Sanofi's Sarclisa for multiple myeloma, based on the IRAKLIA study showing non-inferiority to IV. The drug will be used with the CirCLIQ wearable injector, with median injection time of 13 minutes at home.GlobeNewswireEnable Injections Announces CE Certification of the enFuse® On-Body Delivery System for Use with Aspaveli® Distributed by SobiEnable Injections received CE Certification from the European Union Medical Device Regulation for its enFuse On-Body Delivery System to be used in combination with Aspaveli (pegcetacoplan), commercialized as ASPAVELI enFuse and distributed by Sobi across the EU. The wearable device enables subcutaneous administration of the drug for patients 12 years and older with paroxysmal nocturnal hemoglobinuria, C3G, and primary IC-MPGN, offering an alternative to intravenous infusion. The certification expands a strategic partnership between Enable and Sobi that also includes regulatory clearances in Saudi Arabia, Brazil, South Korea, and Canada.